Clinical Trial to Compare Apatinib Plus Irinotecan Versus Single Irinotecan as Second-line Treatment in AGC or EGJA

NCT03030937 | Unknown Phase 2 DMC

• 1 other identifier: Arise-FJ-G201
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether apatinib plus irinotecan can improve progression free survival compared with single irinotecan in patients with advanced gastric cancer or adenocarcinoma of esophagogastric junction who failed one lines of chemotherapy.

Conditions

Advanced Gastric Cancer Adenocarcinoma of Esophagogastric Junction

Outcome Measures

Primary Outcomes (2)

• Progression-Free Survival (PFS)

  18 months

• Adverse Event（AE）

  NCI CTC 4.03

  18 months

Secondary Outcomes (4)

• Objective Response Rate (ORR)

  18 months

• Disease Control Rate (DCR)

  18 months

• Overall Survival(OS)

  18 months

• Quality of Life (QoL)

  18 months

Study Arms (2)

Irinotecan plus apatinib

EXPERIMENTAL

Irinotecan:160mg/m2, ivgtt,given on the eighth day; Apatinib:initial dose:250mg,oral,once a day, after meal ( try to take the medicine at the same time of the dauntoy ). Repeat the therapeutic schedule every 2 weeks till progressive disease or intolerable toxicities.

Drug: Apatinib; Drug: Irinotecan

Irinotecan

ACTIVE COMPARATOR

Irinotecan:180mg/m2, ivgtt,given on the eighth day. Repeat the therapeutic schedule every 2 weeks till progressive disease or intolerable toxicities.

Drug: Irinotecan

Interventions

Apatinib DRUG

Apatinib, a novel targeted inhibitor of VEGF receptor 2 (VEGFR2).

Irinotecan plus apatinib

Irinotecan DRUG

Irinotecan was used as second line treatment with AGC.

Irinotecan; Irinotecan plus apatinib

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age：18\~70years;
• Subjects with Histologically or cytologically confirmed advanced gastric cancer or adenocarcinoma of esophagogastric junction ；
• Subjects must have received no more than one lines treatment before participating,and have received no irinotecan or antiangiogenic（including apatinib）treatment previously; Note：(1) Time of first-line treatment for subjects with advanced tumour must more than 1 cycles;(2) Adjuvant / neoadjuvant therapy was allowed; adjuvant / neoadjuvant therapy will be considered as a first-line treatment if disease recurrence during treatment or after less than 24 weeks.
• subjects with at least one measurable lesion as defined by RECIST (version 1.1);Lesions previously treated with radiotherapy or locoregional therapy must show radiographic evidence of disease progression to be deemed a target lesion.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1；
• Survival expectation≥ 3 months;
• The interval of subjects had received cytotoxic drugs, radiotherapy or surgery must more than 4 weeks(besides nitroso or mitomycin must more than 6 weeks), and the wound has healed before participating;
• No serious concomitant diseases(including heart,lung,liver jaundice or gastrointestinal obstruction and so on );
• Adequate organ functions defined as indicated below： （1）Adequate bone marrow function, defined as: (no blood transfusion within 14 days)
• Hemoglobin (Hb)≥80g/L，
• White blood count (WBC)≥3.5×109/L
• Absolute neutrophil count (ANC)≥1.5×109/L，
• Platelet count (PLT)≥75×109/L； （2）Adequate liver function, defined as:
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• Bilirubin ≤1.5×the upper limit of normal (ULN)

You may not qualify if:

• Females are lactating or pregnant at Screening or Baseline
• Subjects with other active malignancy (except for definitively treated melanoma in-situ, basal or squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix)
• Subjects with symptomatic brain metastases；
• Subjects with uncontrolled blood pressure with medication (140/90 mmHg),
• Subjects with coronary heart disease (CHD) above grade I, arrhythmia (including Prolongation of QTc interval : Male subjects \> 450 ms, Females\> 470 ms) or cardiac dysfunction;.
• Subjects with gastrointestinal bleeding tendency,including the following: current of local active ulcerative lesions with fstool OB (+ +); history of melena or hematemesis within past 2 months ; current of fstool OB (+) with gastric primary tumor without surgical , investigator considerd ulcerative stomach cancer is associated with risks of gastrointestinal bleeding.
• Subjects with bleeding tendency ，defined as abnormal coagulation (INR\>1.5×(ULN),APTT\>1.5 ×(ULN));
• Subjects with previous history of cardiovascular and cerebrovascular diseases ,those receiving thrombolytics or anticoagulants were excluded
• Subjects with urine protein positive (defined as urine protein detection 2+ or above, or urine protein ≥ 1 g/24 hours );
• Subjects with a variety of factors that affect oral medications (such as inability to swallow, persistent nausea and vomiting, chronic diarrhea and intestinal obstruction, and so on.);
• Subject with any other condition that in the opinion of the investigator would preclude his/her participation in a clinical study.

Sponsors & Collaborators

• Fujian Cancer Hospital: lead

Study Sites (1)

Jianwei Yang

Fuzhou, Fujian, 350000, China

Location

MeSH Terms

Interventions

apatinib; Irinotecan

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• Jianwei Yang

  Fujian Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianwei Yang

CONTACT

008613805097959; swzcq62@163.com

Sha Huang

CONTACT

008613763820570; huangsha0210@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2017
• First Posted: January 25, 2017
• Study Start: February 1, 2017
• Primary Completion: July 31, 2018
• Study Completion: December 30, 2018
• Last Updated: January 25, 2017

Record last verified: 2017-01

Locations

CN (1)